Allogeneic ADSCs and Platelet-Poor Plasma Fibrin Hydrogel to Treat the Patients With Burn Wounds (ADSCs-BWs)
NCT ID: NCT03113747
Last Updated: 2017-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2015-03-25
2018-12-26
Brief Summary
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Detailed Description
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The clinical efficacy of transplantation ADP, after the research done by E.V. Glushchenko; Rahayev AM \[2,3\] is not doubted.
Several studies have shown the efficacy of stem cells in promoting faster and superior wound healing. Alexaki \[4\] successfully used adipose derived mesenchymal stem cells in wound healing in mice and compared their effect with dermal fibroblasts. The application of stem cells in wounds promoted more efficient reepithelialization by their proliferative effect on keratinocytes.
In recent years, the world's leading burn centers attempted to restore the skin over large areas of burn wounds by epidermal layers transplantation of allogeneic cells cultured in culture medium.
The information expected in the study will be based on the principles of evidence-based medicine and will have practical significance for the treatment of burn wounds.
It is expected to show a positive effect of cultured multipotent mesenchymal stromal cells in the epithelization of burn wounds process as well as the extent and speed healing of skin flap during autologous skin grafting.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ALLO-ASCs
The patients receive ALLO-ADSCs. Biological is applied by surface application over perforated (1:3) autologous skin graft following the covering with hypoadhesive bandage. This procedure is carried out twice - once simultaneously with a skin grafting procedure and 2-3 days following autodermoplasty, while bandaging
ALLO-ASCs
1). Cryopreserved cell suspension of early passages of cultured allogeneic MSCs isolated from SVF obtained from lipoaspirate, a total of 10 mln. of cultured cells; 2).The TE-construct consisting of collagen- or fibrin-derived hydrogels and cells of early passages (up to P5) suspension of allogeneic cultured MSCs isolated from SVF obtained from lipoaspirate; Biological is applied by surface application over perforated (1:3) autologous skin graft following the covering with hypoadhesive bandage. This procedure is carried out twice - once simultaneously with a skin grafting procedure and 2-3 days following autodermoplasty, while bandaging.
The standard treatment
All patients will be subjected to standard stepped treatment of burn wounds:
* Infusion therapy aimed to eliminate disorders of homeostasis during burn shock and burn toxemia;
* Systemic antibiotic therapy for preventing infectious complications;
* Adequate analgesia and sedation;
* Decompression necrotomy in the first 24 hours following the burn trauma;
* Necrectomy simultaneously with imposition of lyophilized xenografts performed in the first 1-5 days after applying burn;
* Autologous skin grafting 3-5 days after performed xenografts with the perforation coefficient 1:3
No interventions assigned to this group
Interventions
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ALLO-ASCs
1). Cryopreserved cell suspension of early passages of cultured allogeneic MSCs isolated from SVF obtained from lipoaspirate, a total of 10 mln. of cultured cells; 2).The TE-construct consisting of collagen- or fibrin-derived hydrogels and cells of early passages (up to P5) suspension of allogeneic cultured MSCs isolated from SVF obtained from lipoaspirate; Biological is applied by surface application over perforated (1:3) autologous skin graft following the covering with hypoadhesive bandage. This procedure is carried out twice - once simultaneously with a skin grafting procedure and 2-3 days following autodermoplasty, while bandaging.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with 2-nd B and 3-d degree burn wound;
* Body surface area involved in burns - from 10 to 50%;
* The area of skin grafting - less than 6% of the skin surface;
* Burn occurring within the 24 hours prior to the hospitalization;
* Adequate antishock therapy in the prehospital phase;
* Women of childbearing age to provide proof of a current, valid negative pregnancy test;
* Confirmation of participation in the study by signing the Instrument of Consent, personally or through a responsible caretaker.
Exclusion Criteria
* (Lesion Severity Index, less than 30 or more, than 120 score);
* Combined trauma;
* Severe respiratory tract burn injuries;
* Ischemic disease of the lower extremities;
* The presence of cardiovascular disease (CVD): symptoms of unstable angina, myocarditis, heart disease, heart failure;
* History of prior cancer;
* Healing of duodenal or gastric ulcers in history;
* Diabetes
* Severe chronic liver diseases or kidney disease in history;
* History of alcohol or other drug abuse;
* Pregnanсy;
* Any other physical diseases in decompensation or subcompensation,
* or those that are rated as severe or moderate;
* Therapeutic issues or psychiatric disorders of a patient which would
* make the subject unsuitable to participate in this study or to complete it;
* Participation in another clinical trial
18 Years
65 Years
ALL
No
Sponsors
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A.A. Partners, LLC
OTHER
Responsible Party
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Principal Investigators
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Anatoliy V. Voronin
Role: PRINCIPAL_INVESTIGATOR
The head doctor of The Kyiv City Clinical Hospital №2
Georgiy P. Kozynets, MD, PhD, DSc
Role: PRINCIPAL_INVESTIGATOR
Head of the department of combustiology and plastic surgery, Shupyk National Medical Academy of Postgraduate Education
Locations
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The Kyiv City Clinical Hospital №2
Kyiv, , Ukraine
Countries
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Central Contacts
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Facility Contacts
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References
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Alexaki VI, Simantiraki D, Panayiotopoulou M, Rasouli O, Venihaki M, Castana O, Alexakis D, Kampa M, Stathopoulos EN, Castanas E. Adipose tissue-derived mesenchymal cells support skin reepithelialization through secretion of KGF-1 and PDGF-BB: comparison with dermal fibroblasts. Cell Transplant. 2012;21(11):2441-54. doi: 10.3727/096368912X637064. Epub 2012 Apr 10.
Related Links
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Adipose tissue-derived mesenchymal cells support skin reepithelialization through secretion of KGF-1 and PDGF-BB: comparison with dermal fibroblasts.
2\. Allografting of cultured fibroblasts on nonhealing wounds after autodermoplasty. D. S. Sarkisov, E. V. Glushchenko, Sh. R. Gurukov, S. S. Morozov, V. P. Tumanov, N. V. Berezhkov Bulletin of Experimental Biology and Medicine/May 1991, Volume 111, Issue
3\. Alekseev AA, Krutikov MG, Rakhaev AM/ Treatment of border burns and donor wounds with cultured allofibroblasts// Annals of Surgery. 2001. № 1. С. 59-65.
4\. Alexaki V.-I. et al. Adipose tissue-derived mesenchymal cells support skin reepithelialization through secretion of KGF-1 and PDGF-BB: comparison with dermal fibroblasts. Cell Transplantation. 2012;21(11):2441-2454.
Other Identifiers
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MSC-P1
Identifier Type: -
Identifier Source: org_study_id
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